Impact of Probiotics on Neuropathy Induced by Adjuvant Chemotherapy in Patients With Colon Cancer.

Официальное название

Impact of Probiotic Supplementation on Neuropathy Induced by Adjuvant Chemotherapy in Patients With Colon Cancer: a Phase III Randomized Study

Обзор

The pbjective of this study is to assess the impact of a multi-strain bacteria probiotic OXXYSLAB® on the reduction of oxaliplatin-induced peripheral neuropathy in patients with stage III colon cancer receiving FOLFOX or XELOX regimen in adjuvant treatment, assessed using the oxaliplatin-specific scale of Levi.

Подробное описание

Patients are randomized (1:1 ratio), between:

* Experimental group: Multi-strain PROBIOTIC treatment (OXXYSLAB®) 1.5 g sachet containing maltose and the OXXYSLAB® multi-strain probiotic formulation (eight different live bacterial strains, 200 billion bacteria). * Control group: PLACEBO treatment 1.5 g sachet strictly identical to OXXYSLAB®, containing maltose only.

Вмешательства

• Пищевая добавка PROBIOTIC SUPPLEMENTATION BY OXXYSLAB®
  PROBIOTIC treatment (OXXYSLAB®) starts 1 week before first administration of chemotherapy (XELOX or FOLFOX) and be continued until 1 week after end of the last cycle of chemotherapy. PROBIOTIC treatment (OXXYSLAB®) is administered orally , in 1 daily dose.
• Пищевая добавка PLACEBO supplementation
  PLACEBO supplementation starts 1 week before first administration of chemotherapy (XELOX or FOLFOX) and be continued until 1 week after end of the last cycle of chemotherapy. PROBIOTIC treatment (OXXYSLAB®) is administered orally , in 1 daily dose.

Первичные конечные точки

• Proportion of patients who experience a grade ≥2 peripheral neuropathy [Срок оценки: Around week 12 (+/- 7 days) after initiation of treatment]

Критерии участия

Критерии включения

• Patient ≥ 18 years
• Patient with histologically confirmed stage III adenocarcinoma colon cancer with curative resection
• Patient with an indication to start adjuvant oxaliplatin-based chemotherapy (FOLFOX 4 or XELOX regimen)
• ECOG performance status score of 0 or 1
• Patient must consent to allow the collection of fecal and blood samples during study for further ancillary studies
• Screening laboratory values must meet the following criteria:
• Neutrophils ≥ 1500/ mm³; Platelets ≥ 100 000/ mm³; Hemoglobin ≥ 9.0 g/dL
• Bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 3 x ULN
• Serum creatinine ≤ 1.5 x ULN or measured or calculated creatinine ≥ 50 ml/min clearance (CrCl) (using the Cockcroft-Gault formula)
• Patient with French language comprehension
• Female subject of childbearing potential must have a negative urine or serum pregnancy test within 7 days before study probiotics supplementation start
• Patient in reproductive age must be willing to use adequate contraception during study probiotics supplementation
• Patient affiliated to an appropriate social security system
• Patient has signed informed consent obtained before to any study specific procedures

Enclusion Criteria:

• Patient with any distant metastasis
• Patient with current peripheral neuropathy of any grade or ongoing treatment prescribed to prevent or treat peripheral neuropathy
• Patient with hypersensitivity to any ingredients in the composition of the multi-strain formulation and/or maltose
• Patient with history of acute pancreatitis
• Patient seriously immunosuppressed
• Patient with history of other malignancy within the previous 3 years (except for appropriately treated in-situ cervix carcinoma and non-melanoma skin carcinoma)
• Patient using of probiotics or antibiotic treatments within one month before inclusion
• Patient with chronic inflammatory gastro-intestinal disease
• Patient with uracilemia ≥ 16 ng/ml
• Patient with QT/QTc > 450 msec for men and > 470 msec for women
• Patient with active infection requiring systemic therapy
• Patient with personality disorder or any other known progressive psychiatric pathology
• Patient with neurological previous history with ongoing symptoms (sequelae of head trauma, stroke, multiple sclerosis, epilepsy, neurodegenerative pathology, etc.)
• Patient with dependence on alcohol and / or drugs
• Pregnant or lactating woman
• Simultaneous participation in another clinical study that may compromise the conduct of this study.
• Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
• Patient deprived of liberty or placed under the authority of a tutor

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Франция · 7 центров

• Centre François Baclesse — Caen
• Ch Aunay-Bayeux — Bayeux
• CHU — Caen
• Centre Oscar Lambret — Lille
• CHU — Lille
• CHU — Rouen
• CH — Saint-Lô

Идентификаторы

NCT: NCT07733817 · 2026-A00155-46 · 2026-A00155-46

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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